GYNOZOL Vaginal soft gelatin capsules

Each vaginal soft gelatin capsules contains Miconazole nitrate 200mg or 400mg.

Indications

Local treatment of vulvovaginal mycosis superinfected or not by gram-positive bacteria

Posology/mode of administration

In most cases, the duration of treatment is 3 days: insert deeply into the vagina 1 capsule at bedtime, preferable in reclining position.

Complete the entire treatment even if symptoms (for example: itching and vaginal discharge) have disappeared or if menstruation begins

In case of recurrent or severe mycosis, it may be advisable to prescribe a 6 day treatment

Recommendations for use

• Wash hands thoroughly before and after administration of the product
• Wash with soap of neutral or alkaline pH
• The treatment will be accompanied by hygienic measures (wearing cotton underwear, avoid use of vaginal douching,….) and to the possible extent, the elimination of predisposing factors
• For treating the extension of vulvar or perianal fungus, it is recommended to combine Gynozol vaginal soft gelatin capsules with antifungal cream applied locally
• Do not interrupt the treatment during the menstruation

Contraindications

Gynozol vaginal soft gelatin capsules should not be used in case of hypersensitivity to the active substance or to any of the excipients (or cross sensitivity with other members of the imidazole group)

Avoid latex diaphragms or latex condoms

Special warnings and precautions for use

• This medicine is not recommended during lactation
• With spermicides
• In absence of diagnosis of symptoms, the finding of candida on the skin or mucous membranes cannot constitute in itself an indication
• To confirm candidiasis, the ecological factors should be carefully observed for the development of the fungus. This is indispensable to avoid elapse and for eradication or compensation of predisposing factors
• It is advisable to treat simultaneously any recognized pathogenic candidate
• In case of local intolerance or allergic reaction, treatment should be discontinued
• It is not advisable to use a soap with acidic pH (pH favouring the multiplication of the candida)

Interactions with other medicinal products

Male condoms latex/ latex diaphragm: risk of rupture of diaphragm or the latex condom when used with vaginal capsules or lubricants containing mineral oils (paraffin, silicone,)

With spermicides: all local vaginal treatment may inactivate local spermicidal contraception.

Fertility, pregnancy and lactation

Pregnancy

Studies on animals have shown no evidence of teratogenicity. In the absence of teratogenic effect in animals, teratogenicity in human is not expected. In fact, now substances responsible for the malformations in human have proved to be teratogenic in the animals during well-conducted studies in two species

Clinical studies on pregnant women have shown no malformation or foetotoxic action of this medicine

Lactation

As a precaution, this medication is not recommended during lactation, due to the absence of sufficient data on the secretion of miconazole nitrate in milk

Pharmacodynamics

Pharmacotherapeutic class: anti-infectives and anti-septics, for gynaecological use.

Miconazole nitrate is an imidazole derivative with antifungal and anti-bacterial activity. The antifungal activity has been demonstrated in vitro, miconazole acts on muco-cutaneous fungal infections:

• Dermatophytes (trichophyton, epidermophyton, microsporum)
• Candida and other yeasts
• Malessezia furfur (agent of tinea captis and tinea versicolor)
• Molds and other fungi

The antibacterial activity has been demonstrated in vitro against gram-positive bacteria

Mechanism of action

Different from that of antibiotics, it is located at several levels: membranous (increase of the permeability), cytoplasmic (inhibition of oxidative processes in the mitochondria level), nuclear (inhibition of RNA synthesis)

Activity on Corynebacterium minutissium (erythrasma)

Activity on actinomycetes